Long term extension of a randomised controlled trial of probiotics using electronic health records

Scientific Reports
Gareth DaviesMike Gravenor

Abstract

Most randomised controlled trials (RCTs) are relatively short term and, due to costs and available resources, have limited opportunity to be re-visited or extended. There is no guarantee that effects of treatments remain unchanged beyond the study. Here, we illustrate the feasibility, benefits and cost-effectiveness of enriching standard trial design with electronic follow up. We completed a 5-year electronic follow up of a RCT investigating the impact of probiotics on asthma and eczema in children born 2005-2007, with traditional fieldwork follow up to two years. Participants and trial outcomes were identified and analysed after five years using secure, routine, anonymised, person-based electronic health service databanks. At two years, we identified 93% of participants and compared fieldwork with electronic health records, highlighting areas of agreement and disagreement. Retention of children from lower socio-economic groups was improved, reducing volunteer bias. At 5 years we identified a reduced 82% of participants. These data allowed the trial's first robust analysis of asthma endpoints. We found no indication that probiotic supplementation to pregnant mothers and infants protected against asthma or eczema at 5 years. Con...Continue Reading

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Citations

Jul 31, 2020·Nutrients·Elisabet Navarro-TapiaVicente Andreu-Fernández
Nov 15, 2018·Clinical Reviews in Allergy & Immunology·Aaron Ver HeulAndrew L Kau
Aug 18, 2020·Journal of Immunology Research·Li ChunxiSu Jin
Apr 4, 2021·Pediatric Allergy and Immunology : Official Publication of the European Society of Pediatric Allergy and Immunology·Carol Stephanie C Tan-LimAimee Lou M Nano

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Clinical Trials Mentioned

ISRCTN26287422

Software Mentioned

PROBAT
SAIL

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